BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UROMAX ULTRA¿

    MDR report key: 6034357 · Received October 17, 2016

    Report

    Report Number
    3005099803-2016-03153
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 29, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    EZN
    PMA / PMN Number
    K980795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED UROMAX ULTRA BALLOON CATHETER IDENTIFIED NO DAMAGE TO THE TIP SECTION OF THE DEVICE. A PINHOLE LEAK WAS OBSERVED 1MM PROXIMAL TO THE PROXIMAL EDGE OF THE PROXIMAL MARKERBAND. VISUAL AND TACTILE EXAMINATION IDENTIFIED SEVERAL KINKS IN THE CATHETER SHAFT AT VARIOUS LOCATIONS ALONG ITS LENGTH. THE KINKS ARE CONSISTENT WITH EXCESSIVE FORCE HAVING APPLIED TO THE SHAFT. THIS TYPE OF DAMAGE IS CONSISTENT WITH AN EXCESSIVE FORCE HAVING BEEN APPLIED TO THE SHAFT. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON CATHETER WAS USED IN THE RIGHT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6), 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE AND NOTED A KINK ON THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX BALLOON CATHETER WAS USED IN THE RIGHT URETER DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON FAILED TO INFLATE AND NOTED A KINK ON THE CATHETER SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686647 UROMAX ULTRA¿ DILATOR, CATHETER, URETERAL EZN BOSTON SCIENTIFIC - GALWAY M0062251080 0018976710

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR